Diploma in ICH-GCP Managed Trials

Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials

13 - 15 Mar 2024

or

11 - 13 Sep 2024

On location

Danish

20,200 DKK ex VAT

(app. 2,716 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course consists of presentations from authorities and experts in clinical trials complemented by group work and cases.

The starting point of this course is current legislation and guidelines and the different roles and responsibilities of monitors and investigators/study nurses.

Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.

To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.


This is what course participants say

"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."

Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.


"It was a very well-structured course, which academically had a high level." 

Pernille Skovby, National Coordinator at DanPedMed.


Keywords

  • Good Clinical Practice ICH-GCP
  • National legislation
  • Audit and inspection
  • Essential documents
  • Safety reporting
  • Site management from site and sponsor’s/CRO’s perspective

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Course leader & lecturers

  • Lene Palfelt
    Course leader
    Competency Development Specialist
    Novo Nordisk A/S
  • Amalie Engemand Henriksen
    Lecturer
    Associate Director, Global Clinical Drug Supply
    Genmab A/S
  • Eva Gjerlevsen Harreskov
    Lecturer
    Project Data Manager
    Novo Nordisk A/S
  • Jeanette Blom
    Lecturer
    GCP Koordinator
    GCP-enheden
  • Lene Eskildsen
    Lecturer
    Head of Quality Assurance
    Vicore Pharma AB
  • Malene Hansen
    Lecturer
    RBQM Specialist
    Novo Nordisk A/S
  • Pernille Ask Aabo
    Lecturer
    GCP Koordinator; M.Sc.Pharm
    GCP-enheden
  • Christine Boiden Søtofte
    Lecturer
    DPO-konsulent, cand.jur.
    Center for Politik og Kommunikation, Region Hovedstaden
  • Heidi Filtenborg Madsen
    Lecturer
    Senior Specialist, QPPV Office
    Lundbeck A/S
  • Lene Grejs Petersen
    Lecturer
    Chefkonsulent
    Lægemiddelstyrelsen
  • Solveig Nordahl Jacobsen
    Lecturer
    Akademisk medarbejder, cand.pharm.
    National Videnskabsetisk Komité
  • Trine Welløv Boesgaard
    Lecturer
    Medical Director
    Novo Nordisk A/S
See all

Is this course for you?

This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.

What you will learn

  1. How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
  2. What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
  3. How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
  4. How to collect, monitor and file clinical trial related data throughout the clinical trial
  5. The importance of timely and accurate management of safety data
  6. The importance of correct handling of study medication from packaging to destruction

What your company will get

  1. A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
  2. A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
  3. A GCP professional who knows the principles and practical aspects of effective site monitoring
  4. An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
  5. An employee who understands the responsibilities and duties of both investigator and sponsor

Course calendar

Choose your starting date
Starting 13 Mar 2024
Starting 11 Sep 2024
Starting 9 Dec 2024
13 Mar 2024 10:00-17:25

Day 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
14 Mar 2024 8:30-17:40

Day 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
15 Mar 2024 8:30-15:25

Day 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

11 Apr 2024 10:00-13:00
Go to exam page

Registration

Registration deadline
6 Mar 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Sold out
11 Sep 2024 10:00-17:25

Day 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
12 Sep 2024 8:30-17:40

Day 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
13 Sep 2024 8:30-15:25

Day 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

10 Oct 2024 10:00-13:00
Go to exam page

Registration

Registration deadline
4 Sep 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
11 - 13 Sep
9 Dec 2024 9:00-16:00

Day 1

  • Basic study design
  • ICH-GCP
    • The role and responsibility of investigators
    • Investigator’s oversight (R2)
    • The role and responsibility of sponsors
  • Group work
  • Involved authorities
  1. The Danish Medicines Agency
  2. The Privacy Act
  3. The National Committee on Health Research Ethics
10 Dec 2024 9:00-16:00

Day 2

  • Essential documents
    • Protocol
    • ICF
    • Delegation log
    • Site file - Contract + SOP contracts
    • Areas of responsibilities for site and monitor
    • Clinical trial data handling (collection)
    • Standards for trial data
    • Standards for record keeping
    • CRF
    • Source data list
  • Workshop
  • Safety reporting
    • Definitions - Standards for reporting
    • Areas of responsibilities for site and monitor
  • Handling of medicine in clinical trials
    • Distribution of roles – site vs. monitor
    • Accountability
    • Recipient control on site
    • Labeling incl. add-on labeling
    • Destruction
    • Annex 13
11 Dec 2024 9:00-16:00

Day 3

  • Clinical trial data handling (monitoring)
    • Access to electronic patient journals
    • Risk based monitoring - SDV/SDR - Data management
  • Practical monitoring and collaboration between monitor and site
Practical information

Related exams

10 Jan 2025 10:00-13:00
Go to exam page

Registration

Registration deadline
24 Nov 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
9 - 11 Dec
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus.

Prerequisites

Experience with contractual relations in clinical trials is an advantage, but not a requirement.

Examination

The exam is held online, usually 4-6 weeks after the course.

You will receive a link with exam questions via your personal Atrium log-in.

In order to participate in the exam, you must have attended the course.

Course leader

Lene Palfelt
Competency Development Specialist
Novo Nordisk A/S

Lecturers

Amalie Engemand Henriksen
Associate Director, Global Clinical Drug Supply
Genmab A/S
Eva Gjerlevsen Harreskov
Project Data Manager
Novo Nordisk A/S
Jeanette Blom
GCP Koordinator
GCP-enheden
Lene Eskildsen
Head of Quality Assurance
Vicore Pharma AB
Malene Hansen
RBQM Specialist
Novo Nordisk A/S
Pernille Ask Aabo
GCP Koordinator; M.Sc.Pharm
GCP-enheden
Christine Boiden Søtofte
DPO-konsulent, cand.jur.
Center for Politik og Kommunikation, Region Hovedstaden
Heidi Filtenborg Madsen
Senior Specialist, QPPV Office
Lundbeck A/S
Lene Grejs Petersen
Chefkonsulent
Lægemiddelstyrelsen
Solveig Nordahl Jacobsen
Akademisk medarbejder, cand.pharm.
National Videnskabsetisk Komité
Trine Welløv Boesgaard
Medical Director
Novo Nordisk A/S

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Want to know more or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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